QC Stability Data Reviewer

Hello,

I hope you're doing well.

My name is Soundarya, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for QC Stability Data Reviewer based in Boston, MA with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at soundarya.kondra@intellectt.com

Job Title: QC Stability Data Reviewer
Location: Boston, MA
Work Arrangement: Onsite

Experience Level: 3 5 Years

Job Summary:
We are seeking a QC Data Review Specialist to support the review, assessment, and documentation of cGMP stability and quality control analytical data. This role is responsible for ensuring analytical data accuracy, completeness, compliance, and data integrity in accordance with internal procedures, customer requirements, regulatory expectations, and quality standards.

The ideal candidate will have experience reviewing QC analytical documentation, identifying data discrepancies, supporting investigations, and collaborating with cross-functional teams in a regulated pharmaceutical, biotechnology, or life sciences environment.

Key Responsibilities:

• Review and approve cGMP stability and QC analytical data for accuracy, completeness, and compliance with established specifications, SOPs, and regulatory requirements.
• Evaluate analytical documentation to ensure adherence to data integrity standards and Good Documentation Practices (GDP).
• Identify and resolve data discrepancies, documentation errors, deviations, and potential GMP compliance issues.
• Escalate complex quality issues or unclear findings to appropriate technical or quality leadership.
• Prepare stability data summaries, reports, metrics, and trending analyses.
• Support quality investigations and documentation activities related to analytical data review.
• Collaborate with Quality Control, Quality Assurance, laboratory teams, and cross-functional stakeholders to support timely resolution of quality-related issues.
• Apply scientific and compliance knowledge to assess the quality and acceptability of analytical results.
• Maintain accurate records while ensuring compliance with cGMP requirements, SOPs, and applicable regulations.

Required Qualifications & Skills:

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
• 3 5 years of experience in QC, analytical data review, quality assurance, or a regulated laboratory environment.
• Experience working in a cGMP pharmaceutical, biotechnology, or life sciences environment.
• Knowledge of GMP regulations, Good Documentation Practices (GDP), and data integrity principles.
• Experience reviewing analytical laboratory data and quality documentation.
• Strong attention to detail with the ability to identify discrepancies and compliance issues.
• Ability to interpret analytical results, specifications, and laboratory documentation.
• Strong written and verbal communication skills.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity Statement:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Thanks & Regards,
Soundarya
Technical Recruiter
Intellectt Inc
Soundarya@intellectt.com
Direct: 732 204 6899
Desk number: 732 412 6999 Ext: 247